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FDA 510(k) Application Details - K211227
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K211227
Device Name
Hysteroscope (And Accessories)
Applicant
AcuVu Inc.
4546 El Camino Real #211
Los Altos, CA 94022 US
Other 510(k) Applications for this Company
Contact
Sam Mostafavi
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/23/2021
Decision Date
09/15/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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